| Exclusion Criteria: | 1) Hematological malignancies
2) Symptomatic or untreated brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation, and corticosteroids.
3) Myocardial infarction (MI) within 6 months of study day 1, unstable angina, congestive heart failure [CHF] with New York Heart Association [NYHA] > class II, uncontrolled hypertension.
4) Known positive test for human immunodeficiency virus (HIV) infection, hepatitis C virus, or chronic active hepatitis B infection.
5) Major surgery within 1 month of study day 1, unless approved by the sponsor
6) Past or current history of second neoplasm, except for curatively treated non-melanoma skin cancer, carcinoma in situ of the cervix and other primary solid cancer with no known active disease present and no curative treatment administered for the last 3 years.
7) History of seizure disorder or currently on anti-seizure medication.
8) Any co-morbid medical condition that, in the opinion of the investigator, would increase the risk of toxicity.
9) Serum creatinine > 1.5 x ULN; Elevated liver enzymes (AST/ALT) > 2.5 x ULN, or > 5.0 x ULN if secondary to liver metastases; alkaline phosphatase > 2.5 x ULN or > 5.0 x ULN if secondary to bone or liver metastases; or total bilirubin > 1.5 x ULN.
10) Systemic chemotherapy within 21 days of study day 1; Radiation therapy within 21 days of study day 1; Antibody therapy for treatment of underlying malignancy within 1 month of study day 1.
11) Concurrent or prior (within 7 days of study day 1) anticoagulation therapy. (The use of low dose warfarin < 2 mg daily] for prophylaxis against central venous catheter thrombosis is allowed].
12) Concurrent use of herbal medications taken with the intent to treat cancer, including St. John's Wort.
13) Currently receiving platelet or GCF support for any medical condition. Radiation therapy is not permitted throughout the course of the study.
14) Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s) not approved for any indication.
15) Subject of child bearing potential who is evidently pregnant (e.g., positive HCG test) or breast feeding.
16) Subject of child bearing potential, or subject who has a partner of child bearing potential, and is not using adequate contraceptive precautions.
17) Subject previously has enrolled in this study.
18) Subject will not be available for follow-up assessment.
19) Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or comply with the study procedures.
20) Concurrent chemotherapy with any agent other than BSI-201 or radiation therapy is not permitted throughout the course of the study.
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